Ampicillin/Ampicillin Trihydrate

Sold as Penbritin, Principen '250', Principen '500', Polycillin. Every FDA application for this active ingredient: 5 branded and 34 generic.

As of Nov 15, 2026, FDA lists 39 applications for Ampicillin/Ampicillin Trihydrate (sold as Penbritin, Principen '250', Principen '500' and others), with 0 new uses approved and 0 published complete response letters.

First approved: not available
Applications: 39
New uses approved: 0
Complete response letters: 0

Clinical Trials

143 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Safety of Vonoprazan-Amoxicillin Dual Therapy Versus Concomitant Quadruple Therapy for H. Pylori EradicationHELICOBACTER PYLORI INFECTIONS · Ignacio Moratorio	Phase 4	Recruiting	Nov 9, 2026
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.Helicobacter Infection · Nanjing First Hospital, Nanjing Medical University	Phase 3	Recruiting	Oct 29, 2026
Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar ExtractionWisdom Tooth Removal, Antibiotic Prophylaxis · Dow University of Health Sciences	Phase 4	Recruiting	Oct 26, 2026
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive SurgerySurgical Wound Infection, Neck Infection · Tejs Ehlers Klug	Phase 4	Recruiting	Oct 26, 2026
Amoxicillin-clavulanate Versus Amoxicillin Versus Placebo in Acute Otitis Media in ChildrenAcute Otitis Media, AOM - Acute Otitis Media · Kuopio University Hospital	Phase 4	Not yet recruiting	Oct 16, 2026
Efficacy and Safety of JP-1366-based Triple Therapy in Helicobacter Pylori-positive SubjectsH. Pylori Eradication Therapy · Onconic Therapeutics Inc.	Phase 3	Not yet recruiting	Oct 15, 2026
Comparison of Topical Antibiotics Versus Systemic Antibiotics in Preventing Burn Wound Infection in Pediatric Burn PatientsBurn · abdul mateen	Not applicable	Not yet recruiting	Oct 13, 2026
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated AppendicitisAppendicitis Perforated, Appendectomy, Laparoscopic · McMaster Children's Hospital	Phase 3	Not yet recruiting	Oct 9, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 17, 1965	OmnipenANDA 60624	Wyeth Ayerst	2	Discontinued
May 7, 1970	TotacillinANDA 60666	Glaxosmithkline	0	Discontinued
Mar 3, 1971	PrincipenANDA 61392	Bristol Myers Squibb	3	Discontinued
Mar 3, 1971	PrincipenANDA 61394	Apothecon	4	Discontinued
Aug 3, 1971	Ampicillin TrihydrateANDA 61370	Chartwell Rx	4	Discontinued
Nov 9, 1971	Ampicillin TrihydrateANDA 61502	Chartwell Rx	7	Discontinued
Jan 21, 1974	Ampicillin TrihydrateANDA 61602	Belcher Pharms	1	Discontinued
Mar 6, 1974	Ampicillin TrihydrateANDA 61601	Belcher Pharms	1	Discontinued
May 4, 1976	Ampicillin TrihydrateANDA 61980	Purepac Pharm	0	Discontinued
Jul 5, 1977	Pfizerpen-AANDA 62050	Pfizer	0	Discontinued
Dec 2, 1977	Pfizerpen-AANDA 62049	Pfizer	0	Discontinued
Aug 2, 1979	TotacillinANDA 62212	Glaxosmithkline	1	Discontinued
Aug 27, 1979	TotacillinANDA 62223	Glaxosmithkline	2	Discontinued
Feb 25, 1988	Ampicillin TrihydrateANDA 62883	Strides Pharma Intl	10	Discontinued
Feb 25, 1988	Ampicillin TrihydrateANDA 62882	Strides Pharma Intl	12	Discontinued
Mar 4, 1988	PrincipenANDA 62888	Apothecon	0	Discontinued
Feb 10, 1989	Ampicillin TrihydrateANDA 62982	Ph Health	9	Discontinued
Aug 29, 1995	Ampicillin TrihydrateANDA 64082	Sandoz	8	Marketed
Oct 31, 2023	Ampicillin TrihydrateANDA 216554	Aurobindo Pharma	1	Marketed
—	Ampicillin TrihydrateANDA 61853	Purepac Pharm	0	Discontinued
—	AmcillANDA 62030	Parke Davis	0	Discontinued
—	PenbritinNDA 50019	Wyeth Ayerst	0	Discontinued
—	Principen '250', Principen '500'NDA 50056	Apothecon	0	Discontinued
—	PolycillinNDA 50093	Bristol	0	Discontinued
—	PolycillinNDA 50308	Bristol	0	Discontinued
—	PolycillinNDA 50310	Bristol	0	Discontinued
—	Principen '250', Principen '125'ANDA 60127	Apothecon	0	Discontinued
—	TotacillinANDA 60060	Glaxosmithkline	0	Discontinued
—	OmnipenANDA 60625	Wyeth Ayerst	0	Discontinued
—	Ampicillin TrihydrateANDA 60765	Chartwell Rx	0	Discontinued
—	PenbritinANDA 60908	Wyeth Ayerst	0	Discontinued
—	Ampicillin TrihydrateANDA 61387	Vitarine	0	Discontinued
—	Ampicillin TrihydrateANDA 61755	Mylan	0	Discontinued
—	Ampicillin TrihydrateANDA 61829	Mylan	0	Discontinued
—	AmcillANDA 62041	Parke Davis	0	Discontinued
—	Principen '125', Principen '250'ANDA 62151	Apothecon	0	Discontinued
—	Principen '500', Principen '250'ANDA 62157	Apothecon	0	Discontinued
—	Ampicillin TrihydrateANDA 62208	Lederle	0	Discontinued
—	PolycillinANDA 62297	Apothecon	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA